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Biogen expands immunology with RayThera deal
Biogen struck a deal to buy RayThera for up to $1 billion, aiming to add a portfolio of early immunology assets to its pipeline. The acquisition is structured with an undisclosed upfront payment...
IBD pipeline financing and oral PDE4B strategy
cAMPfield Therapeutics raised a $180 million Series A to develop prifemilast, an oral PDE4B-selective therapy for inflammatory bowel disease. The company said the program is intended as an...
Clinical setbacks in oncology: Zynlonta faces safety signal in Phase 3
ADC Therapeutics reported a stumbling block for Zynlonta (loncastuximab tesirine) after Phase 3 results from LOTIS-5 showed higher fatal adverse events in the treatment arm. The antibody-drug...
FDA extends comment window for AI-powered real-time clinical trials pilot
The FDA extended the comment period for its AI-powered real-time clinical trial (RTCT) pilot, giving sponsors and CROs more time to respond to how AI should be used to report endpoint data as...
New FDA-validated diagnostic option for biopsy-infeasible gliomas
NCCN updated its guidelines to recommend cerebrospinal fluid (CSF)-based molecular tumor profiling for high-grade glioma and glioblastoma when tissue biopsy is not feasible. The recommendation...
Novo Nordisk scales manufacturing and expands footprint
Novo Nordisk is stepping up capacity and operational reach through new investments tied to manufacturing expansion. The company said it has invested about $380 million to expand its manufacturing...
Antifungal progress: Phase 3 non-inferiority for olorofim
F2G and Shionogi reported positive Phase 3 results for olorofim, an oral antifungal being developed for invasive aspergillosis. The companies said the drug demonstrated non-inferiority versus an...
Gene-editing delivery clears FDA IND for PKU
Beam Therapeutics received FDA IND clearance for BEAM-304, advancing a liver-targeted base editing program for phenylketonuria (PKU). The company said BEAM-304 uses a lipid-nanoparticle (LNP)...
CAR T and antibody discovery deals reshape immuno-oncology collaborations
Jazz Pharmaceuticals expanded its immuno-oncology discovery footprint by launching a large preclinical collaboration with AbCellera focused on T-cell engaging multispecific antibodies for...
FDA shifts stance on gene therapy filing for Huntington’s
The FDA reversed course on uniQure’s Huntington’s disease gene therapy, clearing a path for the company to submit a marketing application for accelerated approval. UniQure said regulators would...
Biogen buys RayThera for $1B to add anti-inflammatory pipeline
Biogen agreed to acquire RayThera in a backloaded deal valued up to $1 billion, aiming to add preclinical immunology assets to its pipeline. The companies said the transaction would bring...
Phase 3 setback for Novocure’s electric fields in glioblastoma
Novocure reported that its electric fields therapy, when combined with chemoradiation, failed to extend survival in a key phase 3 glioblastoma study. The company said the negative result reduces...
ADC Therapeutics’ Zynlonta faces safety-linked obstacle after Phase 3
ADC Therapeutics disclosed that its antibody-drug conjugate Zynlonta hit a stumbling block after confirmatory phase 3 results in relapsed or refractory diffuse large B-cell lymphoma. The LOTIS-5...
Biotech IPO momentum: Kardigan upsized to $400M
Kardigan raised $400 million in an upsized IPO to fund development of three clinical-stage cardiovascular drugs. The offering came in about 14% above expectations, with the company positioning the...
Regulatory change expands CSF testing guidance for biopsy-infeasible gliomas
The National Comprehensive Cancer Network updated guidelines to recommend cerebrospinal fluid (CSF)-based molecular tumor profiling for high-grade glioma and glioblastoma when tissue biopsy is not...
FDA extends comment period on AI-powered real-time clinical trials pilot
The FDA extended the public comment period for its AI-powered real-time clinical trial (RTCT) pilot, pushing feedback due to June 29. The agency said it granted the additional time after requests...
Takeda’s zasocitinib wins Phase 3 head-to-head in plaque psoriasis
Takeda reported that its oral TYK2 inhibitor zasocitinib (TAK-279) beat Bristol Myers Squibb’s Sotyktu (deucravacitinib) in a head-to-head Phase 3 readout for moderate-to-severe plaque psoriasis....
Evolving guidance for continuous organ distribution operations
Air transportation for organs is expanding alongside new logistics guidance, creating a need for operational tools that coordinate distributed teams. Coverage highlighted how the transition toward...
Assay/diagnostics collaboration: Volition optimizes NETs assay on Sysmex platform
Volition announced a collaboration with Sysmex to optimize its circulating nucleosome-based Nu.Q NETs H3.1 assay on the Sysmex system. The test quantifies neutrophil extracellular traps (NETs) via...
T cell engager dealmaking
Jazz Pharmaceuticals and AbCellera announced a preclinical option-and-license collaboration to discover and develop next-generation T-cell engaging (TCE) multispecific antibodies for GI cancers...